Table 3.
Event | Patients, n | Events, n | Dose Level | Patients, No. |
---|---|---|---|---|
Erythema | ||||
Local reaction <5 cmb | 8 | 11 | 7 high s.c. | b, f, l, m, qc |
4 low s.c. | a, e, n, l | |||
Local reaction >5 cm | 3 | 3 | 1 high s.c. | qc |
2 low s.c. | k, j | |||
Indurationb | 4 | 5 | 3 high s.c. | b, qc |
2 low s.c. | c, e | |||
Burning sensationb | 3 | 4 | 3 high s.c. | d, qc |
1 low s.c. | e | |||
Local reaction, unspecified | 3 | 4 | 1 high s.c. | qc |
3 low s.c. | n, o | |||
Hot flushes | 2 | 2 | 1 high s.c. | qc |
1 low s.c. | p | |||
Pain | 2 | 2 | 1 i.t. | g |
1 high s.c. | qc | |||
Pyrexia | 1 | 2 | 2 i.v. | i |
White cell blood count reduction | 1 | 1 | 1 high s.c. | d |
Swelling | 1 | 1 | 1 i.v. | m |
Swollen lymph nodes | 1 | 1 | 1 high s.c. | f |
Allergic reaction | 1 | 1 | 1 i.v. | h |
Abbreviations: s.c., subcutaneous; i.v., intravenous; i.t., intratumoral; VA, Viscum album L; AE, adverse event.
High s.c. VA applications were products from Abnoba >0.2 mg/mL, Iscador ≥1 mg/mL, or Helixor ≥10 mg/mL; all other s.c. preparations were classified as low s.c. doses.
Expected VA-related AEs.
Patient number q experienced multiple VA-related AEs. The patient numbers h, n, and o reduced their VA doses after experiencing VA-related AEs.